CONSORT

Guidelines

Checklist

Title and abstract

1a Identification as a randomised trial in the title

1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)

1a Page 1

1b Page 1

Introduction

Background and objectives

2a Scientific background and explanation of rationale

2b Specific objectives or hypotheses

2b Page 2

Methods

Trial design

3a Description of trial design (such as parallel, factorial) including allocation ratio

3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons

Page 2

Participants

4a Eligibility criteria for participants

4b Settings and locations where the data were collected

Page 2

Interventions

5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

Page 3

Outcomes

6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

6b Any changes to trial outcomes after the trial commenced, with reasons

Page 3

Sample size

7a How sample size was determined

7b When applicable, explanation of any interim analyses and stopping guidelines

サンプルサイズの決定方法は、書かれていないことが多い。

7a Page 4

7b N/A

Randomisation:

Sequence generation

8a Method used to generate the random allocation sequence

8b Type of randomisation; details of any restriction (such as blocking and block size)

ランダム化の方法も、書かれていないことが多い。

8a Pages 2-3

8b Page 3

Allocation concealment mechanism

9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

Implementation

10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

Blinding

11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how

11b If relevant, description of the similarity of interventions

(Pagbe 3) The researchers, resident participants, and staff informants were blind to allocation at consent and tobaselinedatacollection.Researcherscollectingdata remained blind to allocation but documented if they became unblinded. By the nature of the intervention, care home staff and resident participants could not be blind to allocation group. All Hospital Episode Statistics data were extracted and analysed blind to allocation. The data monitoring committee were not blinded to the allocation for safety events. Treatment allocations were concealed from the study statistician until the main analyses were complete.

Statistical methods

12a Statistical methods used to compare groups for primary and secondary outcomes

12b Methods for additional analyses, such as subgroup analyses and adjusted analyses

12a Page 4

12b なし

Note

subgroup analysis とは何? 目的は?

Results

Participant flow (a diagram is strongly recommended)

13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome

13b For each group, losses and exclusions after randomisation, together with reasons

Recruitment

14a Dates defining the periods of recruitment and follow-up

14b Why the trial ended or was stopped

Pages 4-5

Fig 1 (Page 6)

Baseline data

15 A table showing baseline demographic and clinical characteristics for each group

Table 1 (Page 7)

Numbers analysed

16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

Note

このような解析方法をなんというか?

intention-to-treat analysis 。

この項目は、ITT を行ったかどうか。Page 4 に書かれている。

Outcomes and estimation

17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended

Note

転倒発生率、Barthel index (ADL の点数)、PAM-RC (ADL の点数) は、17a と 17b のどちらに該当するか?

17a Barthel index (ADL の点数)、PAM-RC (ADL の点数) Table 3

17b 転倒発生率 Table 2

Ancillary analyses

18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

N/A

Harms

19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)

N/A

Discussion

Limitations

20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

Generalisability

21 Generalisability (external validity, applicability) of the trial findings

20 Page 8

21 Page 8

Interpretation

22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence

Page 10 Conclusion

Other information

Registration

23 Registration number and name of trial registry

Page 1

Protocol

24 Where the full trial protocol can be accessed, if available

Page 2: the full protocol has been published.\(^9\)

Funding

25 Sources of funding and other support (such as supply of drugs), role of funders

Page 10

あわせて、Competing interests (Conflict of interst) も記載